Efficacy and Safety of Subcutaneous Rocatinlimab in Adults With Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Meta-Analysis of Randomised Placebo-Controlled Trials.

Abstract

Background: Atopic dermatitis (AD) is a relapsing, chronic inflammatory skin disease. Rocatinlimab, an investigational anti-OX40 monoclonal antibody, has been evaluated for moderate-to-severe AD. This systematic review and meta-analysis aimed to evaluate the short-term efficacy and trial-reported safety of subcutaneous rocatinlimab in patients with moderate-to-severe AD.

Methods: We searched PubMed, Ovid MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL) and ClinicalTrials.gov to identify randomised controlled trials (RCTs) comparing rocatinlimab with placebo in patients with moderate-to-severe AD. Only summary-level data from published reports were analysed. Outcomes of interest included treatment efficacy and safety. A random-effects model with Hartung-Knapp-Sidik-Jonkman adjustment was used for the primary pooled analyses. Exploratory subgroup analyses were conducted according to both dose and dosing frequency, with Wald-type confidence intervals used for subgroup-specific pooled estimates involving only two studies.

Results: A total of 1767 patients from 3 RCTs were included. A total of 1305 patients (73.85%) received subcutaneous rocatinlimab. Rocatinlimab was associated with a significantly greater achievement of the pooled estimate for EASI-75 at Week 16 (OR 3.58, 95% CI 1.53-8.40; p = 0.02). The pooled estimate for the vIGA-AD score of 0 or 1 at Week 16 was directionally favourable but imprecise and did not reach statistical significance (OR 4.06, 95% CI 0.56-29.47; p = 0.09) No statistically significant differences were observed in serious adverse events (OR 1.60, 95% CI 0.41-6.26; p = 0.28) or treatment discontinuation due to adverse events (OR 1.28, 95% CI 0.14-11.60; p = 0.68), although confidence intervals were wide.

Conclusion: In adults with moderate-to-severe AD, subcutaneous rocatinlimab demonstrated potential short-term treatment efficacy compared with placebo. However, the available evidence does not establish durable remission, prevention of recurrence, long-term disease modification or a favourable long-term benefit-risk profile. Given the subsequent discontinuation of the rocatinlimab clinical development programme following safety review, these findings should be interpreted cautiously as a synthesis of short-term trial evidence rather than support for future clinical use.